This invention relates to devices for insertion into the mouth for the application of heat or cold to oral tissue to provide a therapeutic effect.
Cryoanesthesia, or the localized application of cold as a means of producing regional anesthesia, for non-parenteral relief of pain is an accepted method for treating oral tissue. The basic physiologic effects of cooling tissue may include decreased local metabolism, vasoconstriction, reduced swelling, decreased hemorrhage, and analgesia. The magnitude and/or type of the effect generally depends upon the application method and duration of the treatment. Cryoanesthesia or cryotherapy may be preferred for a variety of indications, including decreasing swelling or bleeding after oral surgery, to treat bums, to reduce inflammation due to allergic reaction, or to reduce pain. Conventionally, cryoanesthesia or cryotherapy involves external application of ice or cold packs to the jaw or face.
Likewise, heat therapy or thermal treatments may be useful for certain conditions of the oral tissue. For example, application of heat may relieve painful muscle spasms or cramping, or the pain of temporomandibular joint disease or headache. As with cryotherapy, heat therapy conventionally involves application of a hot pack or heating pad to the skin of the jaw or face. The conventional methods of applying heat or cold to oral tissue suffer the drawback that the heat or cold must be conducted through the skin and underlying tissue to the oral tissue to be treated.
There is a need for a device and method for effectively and efficiently providing anesthesia or pain relief to the oral tissue. Specifically, a device and method that may be used to apply heat or cold directly to a localized area of the oral tissue may be especially desirable.
One aspect of the present invention includes the realization that oral thermal therapy can be more effective and efficient if the device is placed in direct contact with oral tissue that is the subject of therapy. Indirect application of heat or cold to oral tissue is less efficient because the thermal energy is conducted through facial skin and the underlying tissue, thereby attenuating the flow of thermal energy into and out of the oral tissue to be treated. Thus, by directly applying heat or cold to a localized area of oral tissue, anesthetic and other effects can be achieved more effectively and efficiently.
The preferred embodiments of the present invention facilitate the application of cold to the gums, which may be especially helpful to reduce pain and swelling before, during, and after dental or other procedures, and for alleviating pain associated with trauma to the oral cavity. The application of cold may also provide relief from mouth sores and headaches, and may be helpful in pretreatment for certain procedures. The device of preferred embodiments may offer a significant advantage over ice cubes, cold drinks, and the like, because it localizes the cold to the gums or oral tissue without affecting the teeth. It is beneficial to avoid contact with the teeth since they are often sensitive to cold. The invention also has the advantages of being reusable and minimally invasive.
One preferred embodiment is a device that can be positioned between the gum line and the inner wall of the cheek. In one aspect of a preferred embodiment, two tube-like, flexible elements are curved in a semicircular shape or other shape similar to the curve of a patient""s gum line. These semicircular elements are preferably connected to each other by two bendable hinge members. The bendable hinge members may be integral with the semicircular elements, or may be removably attached to the semicircular elements by an appropriate joint configuration.
When worn within the mouth, one semicircular element contacts the upper gum, one semicircular element contacts the lower gum, and the hinge members are positioned toward the back of the mouth. The thickness of the semicircular elements is preferably selected such that they extend over the gum area, while minimizing contact with the teeth. The hinge members allow the device to deform slightly when a gently squeezing pressure is applied. Compressing the device in this way facilitates positioning the device in the mouth. The hinge members are also slightly compressed during normal use, and the pressure exerted in opposition to the compression force helps the device remain in position within the mouth. The hinge members preferably operate in a manner that does not risk trauma to the gum or cheek area.
In one preferred embodiment of the invention, the semicircular elements are hollow and are filled with a non-toxic solution that, when cooled, still remains flexible. In an alternative embodiment, the semicircular elements are solid and composed of a material that is capable of retaining cold or heat without the aid of an encapsulated substance. In other embodiments, a spongy material capable of retaining a cooling or heating material is utilized. In each embodiment, the semicircular elements are preferably soft for comfort yet durable so as to avoid compromising the device if it is accidentally bitten or used in conjunction with braces, dentures, or other oral or medical devices or procedures.